The following invention relates generally to a method and apparatus for storing a first substance, preferably dry, activating the first substance with a second substance, preferably a liquid, and subsequently transferring the diluted, mixed substance from storage into a syringe or cannula without the need for a needle and without appreciable contact with ambient air. More particularly, the present invention relates to a storage container for storing a substance that has undergone a lyophilization process and is ready for the introduction of a substance to evolve into a medium that may be then utilized according to its appropriate prescription. More specifically, the instant invention is specifically tailored to inhibit the lability of pharmaceuticals or extend its useful shelf life.
The potency, efficacy, freshness and/or safety of many substances degrade over time. For example, powder mixed with a diluent has a shelf life of 72 hours or less, while lyophilized powder alone has a shelf life of years. FDA regulations require manufacturers to mark their ready to use and unmixed products identifying a date of expiration which states explicitly that the contents contained therein will not be as effective, fresh or safe to use subsequent to the date printed on the identification mark. This is of particular concern to pharmaceutical companies dealing with the efficacy of their pharmaceutical products degrading over time, because of many pharmaceuticals"" labile nature. This degradation may reach a point where using the particular pharmaceutical product beyond the date imprinted on the bottle could result in the pharmaceutical providing no effect, not enough effect or negative effects on persons taking the product as prescribed by the pharmaceutical manufacturer""s directions, distributor""s directions, seller""s directions, product""s directions, pharmacy""s directions and/or the attending physician""s directions. With lyophilized products, directions for use after mixing typically mandate use before a certain number of hours. The onus for proper use at this point shifts from the manufacturer to the caregiver.
The instant invention chronicles the ongoing efforts of the applicant to address the needs of the medical community. Applicant""s issued patents are as follows: U.S. Pat. Nos. 5,102,398; 5,370,626; 5,538,506; 5,716,346; and 6,045,538.
The instant invention inhibits the labile nature of substances. In its most elemental form, the instant invention is a specialized container to store dry product. In particular, the instant invention takes advantage of the lyophilic process and provides a container for storing the lyophilisate to inhibit the lability of pharmaceutical products. In this patent application, the container is to be called an ampule. This container provides an aseptic environment that prevents bacteria from propagating to the pharmaceutical product which would effect the product in an adverse manner. The container is configured to receive liquid in such a way that the dry product can be diluted without appreciable exposure to ambient air. Because powder alone and powder mixed with a substance can be mutagenic, confined mixing without dispersion, released/aero solution or contamination is critical, and the instant invention addresses these critical concerns.
Further, the instant invention provides for a process that dissolves a dry, powdery or dry, pelletized substance stored in a dry, plastic ampule. The ampule has a first coupler defining an outlet which has been sealed during manufacture by occluding the first coupler outlet with a first cap.
To use the dry substance, it must first be dissolved. The cap is removed, exposing the coupler/outlet and liquid is introduced. The powder is dissolved and the resulting mixture is removed for use.
The container is constructed to discourage any appreciable ambient air from contaminating the system. This minimizes nosocomial infections.
Further, the instant invention completely avoids the use of a needle. The instant invention takes advantage of a coupling that is the standard on a majority of syringes which had heretofore only been used in the past to support the hypodermic needle on the syringe. This coupling, called a luer fitting, has a male component and a female component. Typically, the syringe is configured with the xe2x80x9cmalexe2x80x9d luer coupling which appears as a truncated cone that has an opening at its end. Some luer couplings are threaded. The luer coupling typically diverges toward an interior cylindrical hollow portion of the syringe. The coupler of the instant invention replicates the xe2x80x9cfemalexe2x80x9d luer coupling normally associated with the needle per se. Preferably liquid is introduced via a syringe by connecting the respective luer couplers of the syringe and ampule. The coupler provides a tight, reliable seal. The walls of the ampule are flexible. Flexible walls not only promote removal of liquid, but also avoid introducing ambient air into the ampule. Instead of venting air at the coupler, the walls of the ampule flex.
The syringe can be prefilled in as described in U.S. Pat. No. 5,102,398 or can be filled as described in U.S. Pat. No. 5,716,346.
Once filled, the syringe feeds the ampule with liquid for mixing. After mixing, the contents of the ampule is then retransferred back to the syringe (while preferably still docked to the ampule) with none or a minimal, negligible amount of ambient air introduced. The flexible side walls of the ampule can collapse as the liquid from the ampule is loaded into the syringe but it is primarily the coupling that eliminates ambient air invasion.
Once the ampule has been removed, a syringe has the intended mixture of medication disposed therewithin. Unlike the prior art, no needle has yet been involved. Also, no air from the ambient environment has been mixed with the sterile fluid as was the case with rigid wall containers that require pressurization.
In one form of the invention, it is contemplated that the opening associated with the ampule is provided with a removable cap having a luer-type coupling and an indicia bearing tab. The medicinal contents of the ampule is stamped on the tab for identification purposes. With such an arrangement, it is possible to transfer the cap and tab from the ampule and connect the cap to the syringe to provide a tell tale of the contents of the fluid contained within the syringe. As an alternative, the ampule could remain docked to the syringe until actual use to act both as a sterility cap and identify the substance in the syringe because the ampule would also note the contents on a surface thereof.
As a result of this system, the entire process for dissolving and mixing a dry substance and then filling a syringe has been accomplished without the use of a needle. Personnel are able to operate more quickly with less fear of either inadvertent needle stick or inadvertent exposure to the medicine contained within the syringe.
It is to be noted that for many in-patients, the standard procedure in a hospital is to tap into a person""s vein only once with an infusion catheter and to leave the catheter needle in place with tubing communicating therewith so that subsequent fluids such as intravenous drips and the like can be used. With such a system, a needle would never be needed with the syringe according to the present invention. xe2x80x9cYxe2x80x9d connectors are well known in the art, one branch of which and would have a complemental female luer coupling. Thus, for a patient""s entire stay at a hospital, the only needle associated with that one patient, ideally, would be the one which initially had been placed in the patient""s vein to support the infusion catheter. In this way, the opportunity for inadvertent needle sticks would be reduced to a minimum.
Accordingly, the primary object of the present invention is to provide a method and apparatus for transferring sterile fluid from an ampule to a hypodermic syringe after mixing liquid and solids in the ampule without the need of a hypodermic needle and without ambient air contamination.
It is a further object of the present invention to provide a device and method as characterized above which reduces the amount of time which hospital staff must spend in transferring fluid from a sterile ampule to a hypodermic syringe while also eliminating the fear of an inadvertent needle stick, thereby avoiding the possibility of both unwanted contamination and unwanted medication being released into and/or exposed to the air.
A further object of the present invention contemplates providing a device and method as characterized above which is extremely inexpensive to fabricate, safe to use and lends itself to mass production techniques.
A further object of the present invention is to provide a device which can reduce the number of times that needles are required in a hospital or other medical setting.
A further object of the present invention contemplates providing a device and method which minimizes the disposal problems of hypodermic syringes with needles.
A further object of the present invention contemplates providing a device and method for use in which a telltale is associated with first the ampule that stores the medicine, and then the syringe so that the fluid transferred from the ampule and into the syringe will be known at all times. In this way, the chain of custody of the fluid can be more readily monitored.
A further object of the present invention contemplates providing a system for loading syringes that obviates the need for the medicating health professional from having to trundle a miniature pharmacy on a cart from patient to patient. By filling the syringes at the patient""s bed side, added security, safety and efficiency may be provided.
Viewed from a first vantage point it is an object of the present invention to provide a needleless system for mixing a sterile liquid with a dry substance. A syringe docks with an ampule having a substance such as a lyophilized material for mixing and subsequent timely use. The ampule is defined by an end, collapsible side walls extending from the end thereby defining a blind bore and having an open end, a coupler at the open end, and a removable cap occluding the open end at the coupler. The coupler is provided with means to connect to a needleless opening of the syringe to be in fluid communication therewith, whereby fluid can be transferred without an interconnecting needle. When the syringe docks with the ampule, after the liquid and solids are mixed the syringe is loaded with the mixture.
Viewed from a second vantage point, it is an object of the present invention to provide a method for forming an ampule to transfer medicine to be infused in a patient. The steps include forming an ampule with resilient walls so that the ampule can be collapsed, and forming an opening on the ampule. The opening is circumscribed by a coupler which is fashioned to receive a dose administering device. The ampule houses dry medicine. The ampule opening is sealed until use.
Viewed from a third vantage point, it is an object of the present invention to provide for a process that dissolves a dry or powdery or pelletized substance stored in an ampule. The ampule has a coupler defining the outlet and which has been sealed by occluding the coupler outlet with a cap. A needleless syringe is configured with a coupler and an opening which communicates within an interior cylindrical hollow of the syringe so that fluid passes by the coupler through the opening and into the cylindrical hollow and fills the syringe. The steps include removing the cap from the ampule and orient the coupler of the ampule with the coupler of the syringe into complemental, fluid-tight locking engagement so that the opening of the ampule registers with the opening of the syringe. Next, transfer the fluid of the syringe into the ampule; mix the dry substance in the ampule with the fluid from the syringe until the dry substance is dissolved thus making a mixture preferably while the ampule and syringe remain mated. Then convey the mixture back into the syringe for inserting the mixture into a patient. The mixture may be filtered prior to dispensation.
Viewed from a fourth vantage point, it is an object of the present invention to provide for another process for forming an ampule to transfer pharmaceutical grade fluid or solid to be administered. The process includes: forming an ampule with resilient walls so that the ampule can be collapsed and creating an orifice to pass the pharmaceutical grade fluid or solid into the ampule and then sealing the orifice; also forming an opening on the ampule and sealing with a cap. A scoreline at the juncture with the cap is such that the opening defines a coupler which is to be complementally fastened to and receives a dose administering device.
Viewed from a fifth vantage point, it is an object of the present invention to provide for an ampule for storing a pharmaceutical product in a manner to inhibit lability of the product and permitting the transfer of the product in an aseptic manner to avoid nosocomial infection from ambient air. The ampule has resilient walls that can be collapsed and includes an orifice to pass a pharmaceutical grade fluid or solid therethrough and an opening on said ampule whereby the opening defines a coupler which is to be complementally fastened to receive a dose administering device.